Pharmaceutical Formulation Characterization Design, 2nd Edition

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Pharmaceutical Technology".

Deadline for manuscript submissions: 15 September 2026 | Viewed by 1128

Special Issue Editors


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Guest Editor
Institute of Pharmaceutical Technology and Regulatoy Affairs, University of Szeged, Eötvös u. 6., H-6720 Szeged, Hungary
Interests: buccal polymer films; mucoadhesion; proteins; Quality by Design; permeation enhancing
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Guest Editor
Institute of Pharmaceutical Technology and Regulatoy Affairs, University of Szeged, Eötvös u. 6., H-6720 Szeged, Hungary
Interests: solid dosage forms; tablets; Quality by Design; factorial design; artificial neural network
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

This Special Issue of Pharmaceuticals is dedicated to reporting the latest scientific results in the field of "Formulation Characterization Design". At present, it is very important that, before the industrial production of pharmaceuticals, a given pharmaceutical form is extensively tested, which includes various structural tests, physical tests, and pharmacokinetic tests. It is necessary to find out whether there is any change in the active ingredient during pharmaceutical technological processes and whether this could influence the development of the effect. It is necessary to understand the relationships between different structural properties, the dissolution profile, and the effect on development in order to be able to design medicines more efficiently based on new knowledge. Appropriate planning is also very important and can be achieved primarily through risk analysis, the Quality by Design (QbD) approach, and the use of factorial experimental design (DoE). It is possible to determine the design space, which provides accurate information about the Critical Process Parameter (CPP) values, within which the product with the quality target product profile (QTPP) will be suitable. Based on these, we can gain new knowledge and connections that are essential for efficient production later on. This Special Issue primarily publishes results related to the above-mentioned topics or those that are similar, mainly in the field of solid dosage formulation or intermediate products that can be used in them. We welcome papers from both the field of traditional dosage forms such as tablets, granules, and innovative dosage forms such as buccal films, inhalation powders, nasal preparations, transdermal drug delivery systems, etc.

Dr. Katalin Kristó
Dr. Tamás Sovány
Guest Editors

Manuscript Submission Information

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Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceuticals is an international peer-reviewed open access monthly journal published by MDPI.

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Keywords

  • Quality by Design
  • factorial design
  • design space
  • solid dosage forms
  • risk assessment
  • critical process parameters
  • quality target product profile

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Published Papers (1 paper)

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Review

25 pages, 6594 KB  
Review
Ambient-Stable mRNA Medicines: Emerging Paradigms in Dry and Solid-State Formulation
by Mohamed El-Tanani, Syed Arman Rabbani, Adil Farooq Wali, Frezah Muhana, Alaa A. A. Aljabali, Yahia El-Tanani and Rakesh Kumar
Pharmaceuticals 2026, 19(3), 370; https://doi.org/10.3390/ph19030370 - 26 Feb 2026
Viewed by 720
Abstract
The medical field now uses mRNA therapeutics to deliver fast programmable treatment options through versatile vaccination platforms. The worldwide adoption of mRNA therapeutics faces a major obstacle because these molecules require extreme cold storage and transportation systems. mRNA stability establishes a fundamental scientific [...] Read more.
The medical field now uses mRNA therapeutics to deliver fast programmable treatment options through versatile vaccination platforms. The worldwide adoption of mRNA therapeutics faces a major obstacle because these molecules require extreme cold storage and transportation systems. mRNA stability establishes a fundamental scientific and industrial challenge which requires researchers to unite formulation design with process control and material engineering for cold-chain independence. Current knowledge about RNA hydrolysis and lipid oxidation and water-mediated degradation is combined with new methods for solid-state stabilization through lyophilization and spray-freeze-drying and thin-film technologies. Mechanism such as vitrification, water replacement and excipient RNA interactions are assessed to establish the fundamental chemical properties needed for extended product stability. Advanced mRNA development strategies are also examined, including self-amplifying and circular RNA structures and nano-glass and metal–organic frameworks and artificial intelligence-based predictive design for creating stable mRNA formulations at room temperature. This review examines manufacturing and regulatory and logistical obstacles which affect real-world implementation of mRNA therapeutics through assessments of production scale and product quality tests and packaging strength and tropical environment testing. The combination of research findings presents a path to develop mRNA medicines which maintains their effectiveness when stored at 25 °C or above, thus enabling worldwide access to RNA-based treatments. The development of mRNA into a durable therapeutic platform requires scientists to merge molecular research with process development and regulatory standardization. Full article
(This article belongs to the Special Issue Pharmaceutical Formulation Characterization Design, 2nd Edition)
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